Trial · NCT01801358
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
NCT01801358, Phase 1, Phase 2, Terminated, Array Biopharma, now a wholly owned subsidiary of Pfizer; results first posted 2016-10-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma. Trials, record NCT01801358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01801358
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
- NCT number
- NCT01801358
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Conditions
- Uveal Melanoma
- Interventions
- AEB071, MEK162
- First posted
- 2013-02-28
- Last updated
- 2020-09-16
- Results first posted
- 2016-10-20
- Limitations and caveats
- Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Cycle 1 (up to 28 days) | A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162. |
| Primary | Phase II: Progression Free Survival (PFS) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | The time from date of randomization to the date of event defined as the first documented progression or death due to any cause. Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination. |
| Secondary | Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained. |
| Secondary | Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Serious adverse event (SAE) is defined as one of the following: * Is fatal or life-threatening * Results in persistent or significant disability/incapacity * Constitutes a congenital anomaly/birth defect * Is medically significant * Requires inpatient hospitalization or prolongation of existing hospitalization * Note that hospitalizations for the following reasons should not be reported as serious adverse events: * Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition * Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent * Social reasons and respite care in the absence of any deterioration in the patient's general condition |
| Secondary | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR) | Cycle 1 (up to 28 days) | Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. |
| Secondary | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR) | Cycle 1 (up to 28 days) | Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination. Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study. |
| Secondary | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS) | Cycle 1 (up to 28 days) | Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination. PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. |
| Secondary | Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone. Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as 'Objective response rate' in some protocols or publications. Due to an enrollment halt, the Phase II part of the study was not conducted. |
| Secondary | Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Due to an enrollment halt, the Phase II part of the study was not conducted. |
| Secondary | Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone. Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Cycle 1 (up to 28 days) | Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1. | DLTs | NUMBER |
| PRIMARY | Phase II: Progression Free Survival (PFS) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | |||
| SECONDARY | Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment. | participants | NUMBER |
| SECONDARY | Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment. | participants | NUMBER |
| SECONDARY | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR) | Cycle 1 (up to 28 days) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | participants | NUMBER |
| SECONDARY | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR) | Cycle 1 (up to 28 days) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | ||
| SECONDARY | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS) | Cycle 1 (up to 28 days) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | weeks | MEDIAN |
| SECONDARY | Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | ||
| SECONDARY | Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | ||
| SECONDARY | Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS) | Anaemia | 0 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS) | Anaemia | 0 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS) | Anaemia | 0 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS) | Anaemia | 1 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS) | Anaemia | 0 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (DDS) | Anaemia | 0 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS) | Diarrhoea | 0 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS) | Diarrhoea | 0 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS) | Diarrhoea | 2 | DLTs | |
| Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS) | Diarrhoea | 1 | DLTs |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS) | 6 | |
| Overall Study | STARTED | Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS) | 6 | |
| Overall Study | STARTED | Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS) | 6 | |
| Overall Study | STARTED | Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS) | 6 | |
| Overall Study | STARTED | Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS) | 6 | |
| Overall Study | STARTED | Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS) | 8 | |
| Overall Study | COMPLETED | Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS) | 0 | |
| Overall Study | COMPLETED | Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS) | 0 | |
| Overall Study | COMPLETED | Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS) | 0 | |
| Overall Study | COMPLETED | Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events618
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | HYPERTENSION | Vascular disorders | Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS) | 1 | 6 | 1 |
| other | HYPERTENSION | Vascular disorders | Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS) | 0 | 6 | 0 |
| other | HYPERTENSION | Vascular disorders | Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS) | 1 | 6 | 1 |
| other | HYPERTENSION | Vascular disorders | Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS) | 0 | 6 | 0 |
| other | HYPERTENSION | Vascular disorders | Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS) | 0 | 6 | 0 |
| other | HYPERTENSION | Vascular disorders | Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS) | 3 | 8 | 3 |
| other | TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS) | 1 | 6 | 1 |
| other | TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS) | 0 | 6 | 0 |
| other | TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS) | 0 | 6 | 0 |
| other | TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS) | 1 | 6 | 1 |
1 to 10 of 618Source ClinicalTrials.gov
See all 618 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS) | ||
| Total, all-cause mortality | Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS) | ||
| Total, all-cause mortality | Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS) | ||
| Total, all-cause mortality | Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS) | ||
| Total, all-cause mortality | Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS) | ||
| Total, all-cause mortality | Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS) | ||
| Total, other adverse events | Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS) | 6 | 6 |
| Total, other adverse events | Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS) | 6 | 6 |
| Total, other adverse events | Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS) | 6 | 6 |
| Total, other adverse events | Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS) | 6 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01801358
GET https://conductscience.org/api/trials/v1/NCT01801358/registered?page=2